Concomitant Administration of 13-valent Pneumococcal Conj... | NCT02124161 | Trialant
NCT02124161
Sponsor
Pfizer
Status
Completed
Last Update Posted
Jul 1, 2016Estimated
Enrollment
882Actual
Phase
Phase 4
Conditions
PREVENTION OF INVASIVE PNEUMOCOCCAL DISEASE
Interventions
13-valent pneumococcal conjugate vaccine
Seasonal Inactivated Influenza Vaccine
Placebo
Placebo
Seasonal Inactivated Influenza Vaccine
13-valent pneumococcal conjugate vaccine
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT02124161
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
B1851138
Secondary IDs
Not provided
Brief Title
Concomitant Administration of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) With Influenza Vaccine in 23-valent Pneumococcal Polysaccharide (23vPS) Pre-vaccinated Adults.
Official Title
A Phase 4, Randomized, Double-blind Trial To Evaluate The Immunogenicity And Safety Of A 13-valent Pneumococcal Conjugate Vaccine When Administered Concomitantly With Seasonal Inactivated Influenza Vaccine In Adults 50 Years And Older Who Received 1 Or More Doses Of 23-valent Pneumococcal Polysaccharide Vaccine Prior To Study Enrollment.
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Apr 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 2014
Primary Completion Date
May 2015Actual
Completion Date
May 2015Actual
First Submitted Date
Apr 24, 2014
First Submission Date that Met QC Criteria
Apr 24, 2014
First Posted Date
Apr 28, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
May 23, 2016
Results First Submitted that Met QC Criteria
May 23, 2016
Results First Posted Date
Jul 1, 2016Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 23, 2016
Last Update Posted Date
Jul 1, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the immunogenicity and safety of 13-valent pneumococcal polysaccharide vaccine when given concomitantly with seasonal inactivated influenza vaccine to adults 50 years and older who have previously received 23-valent pneumococcal polysaccharide vaccine.
One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes
Serotype-specific OPA GMTs for each of the 13 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were logarithmically transformed for analysis. Confidence intervals (CIs) for GMT were back-transformed based on the Student t distribution for the mean logarithm of the titers. GMTs were calculated using all participants with available data for the specified blood draw. Here, "number of participants analyzed" signifies the participants who were evaluable at this timepoint and "n" signifies participants with a determinate OPA titer to the given serotype.
1 month after Vaccination 1 for 13vPnC+QIV/Placebo, 1 Month After Vaccination 2 for Placebo+QIV/13vPnC
Hemagglutination Inhibition Assay (HAI) Geometric Mean Titers (GMTs) for Each Influenza Virus Strain in Quadrivalent Influenza Vaccine (QIV)
HAI GMTs were computed for assay titers collected 1 month after Vaccination 1 by vaccine sequence for each influenza virus strain (A/H1N1, A/H3N2, B/Brisbane and B/Massachusetts). CIs were back-transformations of a CI based on the Student t distribution for the mean logarithm of the titers. HAI GMTs were calculated using all participants with available data for the specified blood draw. Here, "number of participants analyzed" signifies participants with a determinate HAI titer to the given strain.
1 month after Vaccination 1
Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 1
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).
Within 28 to 42 days after Vaccination 1
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)
Percentage of participants achieving predefined OPA antibody titer >= LLOQ for each of the 13 pneumococcal serotypes (LLOQs for each serotype OPA were set as- serotype 1: 18; serotype 3: 12; serotype 4: 21; serotype 5: 29; serotype 6A: 37; serotype 6B: 43; serotype 7F: 210; serotype 9V: 345; serotype 14: 35; serotype 18C: 31; serotype 19A: 18; serotype 19F: 48; and serotype 23F: 13) determined in blood samples of all participants were calculated. Exact, 2-sided 95% CIs based on the observed percentage of participants were determined by using Clopper and Pearson method. OPA titers were calculated using all participants with available data from 1 month after 13vPnC vaccination blood draw. Here, "number of participants analyzed" signifies the participants who were evaluable at this timepoint and "n" signifies participants with valid and determinate assay results to the specified serotype.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject has been informed of all pertinent aspects of the study.
Male or female adults 50 years of age or older.
Documented vaccination with 1 or more prior doses of 23vPS, the last given at least 1 year prior to study enrollment.
Negative urine pregnancy test for all female subjects who are of child bearing potential.
Exclusion Criteria:
Previous vaccination with Prevnar®, Prevnar 13®, or any other investigational pneumococcal conjugate vaccine.
History of severe adverse reactions associated with any vaccine or vaccine-related component.
Allergic to egg proteins (egg or egg products) and chicken proteins.
882 participants who were greater than or equal to (>=) 50 years of age and previously vaccinated with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) were randomized in this study but 6 participants (2 participants in 13vPnC+QIV/Placebo arm and 4 participants in Placebo+QIV/13vPnC arm) were randomized but not vaccinated.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
13vPnC+QIV/Placebo
Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Not provided
Intervention Model Description
Not provided
Primary Purpose
Basic Science
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
13vPnC+SIIV/Placebo
13vPnC
Seasonal Inactivated Influenza Vaccine
Biological
One (1) dose of SIIV will be administered intramuscularly into the right deltoid of all subjects at Visit 1.
13vPnC+SIIV/Placebo
SIIV
Placebo
Other
One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.
13vPnC+SIIV/Placebo
Placebo
Other
One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.
Placebo+SIIV/13vPnC
Seasonal Inactivated Influenza Vaccine
Biological
One (1) dose of SIIV will be administered intramuscularly into the right deltoid of all subjects at Visit 1.
Placebo+SIIV/13vPnC
SIIV
13-valent pneumococcal conjugate vaccine
Biological
One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.
Placebo+SIIV/13vPnC
13vPnC
Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 2
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).
Within 28 to 42 days after Vaccination 2
Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After 13vPnC Vaccination
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).
Baseline (Vaccination 1) up to 28 to 42 Days after Vaccination 2
Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) at the 6-Month Follow-up
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).
Within 168 to 196 days after Vaccination 2
1 Month After Vaccination 1 for 13vPnC+QIV/Placebo, 1 month after Vaccination 2 for Placebo+QIV/13vPnC
Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 1 to Immediately Before 13vPnC Vaccination 1
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) 1 month after Vaccination 1 to before Vaccination 1 were computed using the logarithmically transformed assay results. CIs for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before Vaccination 1 and 1 month after Vaccination 1 blood draws. Here, "n" signifies participants with valid and determinate assay results for specified serotype at both the given visits. Number of participants who received at least 1 dose of 13vPnC during Vaccination 1 were analyzed.
Immediately before Vaccination 1, 1 month after Vaccination 1
Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 2 to Immediately Before 13vPnC Vaccination 2
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) 1 month after Vaccination 2 to before Vaccination 2 (1 month after Vaccination 1) were computed using the logarithmically transformed assay results. CIs for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before Vaccination 2 and 1 month after Vaccination 2 blood draws. Here, "number of participants analyzed" signifies total participants who were evaluable at this timepoint and "n" signifies participants with valid and determinate assay results for specified serotype at both the given visits. Number of participants who received at least 1 dose of 13vPnC during Vaccination 2 were analyzed.
Immediately before Vaccination 2, 1 month after Vaccination 2
Percentage of Participants Achieving Seroconversion in Hemagglutination Inhibition Assay (HAI) Titers
Percentage of participants achieving seroconversion in HAI titers was defined as the percentage of participants with either before Vaccination 1 (pre-vaccination 1) HAI titer less than <1:10 and after Vaccination 1 (post-vaccination 1) HAI titer >=1:40 or before Vaccination 1 (pre-vaccination 1) HAI titer >=1:10 and a minimum 4-fold rise in after Vaccination 1 (post-vaccination 1) HAI antibody titer with respect to before Vaccination 1 (pre-vaccination) titer for influenza virus strains. Here, "number of participants analyzed" signifies the participants who were evaluable at this timepoint.
Immediately before Vaccination 1, 1 month after Vaccination 1
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition Assay (HAI) 1 Month After Vaccination 1 to Immediately Before Vaccination 1
Fold rise 1 month after Vaccination 1 to before Vaccination 1 was calculated for each influenza virus strain (A/H1N1, A/H3N2, B/Brisbane and B/Massachusetts). GMFRs were calculated using all participants with available data from both the specified blood draws. CI for the GMFRs were back transformations of a CI based on the Student t distribution for mean fold rise. Here, "number of participants analyzed" signifies participants with valid and determinate assay results for specified strain at both the specified blood draws.
Immediately before Vaccination 1, 1 month after Vaccination 1
Huntsville
Alabama
35802
United States
Radiant Research, Inc.
Scottsdale
Arizona
85251
United States
Kaiser Permanente Vaccine Study Center
Oakland
California
94612
United States
Kaiser Permanante South. Sacramento
Sacramento
California
95823
United States
Benchmark Research
San Francisco
California
94108
United States
Kaiser Pemanente Santa Clara
Santa Clara
California
95051
United States
Avail Clinical Research, LLC
DeLand
Florida
32720
United States
Westside Center for Clinical Research
Jacksonville
Florida
32205
United States
Jacksonville Center for Clinical Research
Jacksonville
Florida
32216
United States
Radiant Research, Inc.
Pinellas Park
Florida
33781
United States
Meridian Clinical Research
Savannah
Georgia
31406
United States
Optimal Research, LLC
Mishawaka
Indiana
46545
United States
Clinical Research Advantage, Inc/Ridge Family Practice
Council Bluffs
Iowa
51503
United States
Johnson County Clin-Trials, Inc.
Lenexa
Kansas
66219
United States
Benchmark Research
Metairie
Louisiana
70002
United States
Meridian Clinical Research
Bellevue
Nebraska
68005
United States
Meridian Clinical Research
Norfolk
Nebraska
68701
United States
Meridian Clinical Research, LLC
Omaha
Nebraska
68134
United States
Clinical Research Center of Nevada, LLC
Las Vegas
Nevada
89104
United States
Clinical Research Advantage, Inc.
Las Vegas
Nevada
89128
United States
United Medical Associates
Binghamton
New York
13901
United States
Regional Clinical Research, Inc.
Endwell
New York
13760
United States
Rochester Clinical Research, Inc.
Rochester
New York
14609
United States
PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
Cary
North Carolina
27518
United States
PharmQuest
Greensboro
North Carolina
27408
United States
PMG Research of Hickory, LLC
Hickory
North Carolina
28602
United States
Clinical Trials of America, Inc.
Winston-Salem
North Carolina
27103
United States
PMG Research of Winston-Salem
Winston-Salem
North Carolina
27103
United States
Radiant Research, Inc
Columbus
Ohio
43212
United States
Prestige Clinical Research
Franklin
Ohio
45005
United States
Preferred Primary Care Physicians, Inc.
Carnegie
Pennsylvania
15106
United States
Brandywine Clinical Research
Downingtown
Pennsylvania
19335
United States
Omega Medical Research
Warwick
Rhode Island
02886
United States
PMG Research of Charleston
Mt. Pleasant
South Carolina
29464
United States
Internal Medicine and Pediatric Associates of Bristol, PC
Bristol
Tennessee
37620
United States
Volunteer Research Group
Knoxville
Tennessee
37920
United States
Benchmark Research
Austin
Texas
78705
United States
Benchmark Research
Fort Worth
Texas
76735
United States
Diagnostics Research Group
San Antonio
Texas
78229
United States
Radiant Research, Inc.
Murray
Utah
84123
United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City
Utah
84109
United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City
Utah
84121
United States
J. Lewis Research, Inc. / Jordan River Family Medicine
South Jordan
Utah
84095
United States
FG001
Placebo+QIV/13vPnC
Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
FG000441 subjects
FG001441 subjects
Vaccination 1
FG000439 subjects
FG001437 subjects
Vaccination 2
FG000431 subjects
FG001432 subjects
COMPLETED
FG000425 subjects
FG001426 subjects
NOT COMPLETED
FG00016 subjects
FG00115 subjects
Type
Comment
Reasons
Other unspecified
FG0000 subjects
FG0011 subjects
Death
FG0001 subjects
FG0010 subjects
Protocol Violation
FG0002 subjects
FG0011 subjects
Withdrawal by Subject
FG0001 subjects
FG0012 subjects
Adverse Event
FG0002 subjects
FG0010 subjects
Does not meet entrance criteria
FG0002 subjects
FG0013 subjects
No longer meets eligibility criteria
FG0005 subjects
FG0014 subjects
Lost to Follow-up
FG0003 subjects
FG0014 subjects
Safety population included all participants who received at least 1 dose of vaccination.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
13vPnC+QIV/Placebo
Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
BG001
Placebo+QIV/13vPnC
Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000439
BG001437
BG002876
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00066.9± 9
BG00166.4± 8.85
BG00266.7± 8.93
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000234
BG001249
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes
Serotype-specific OPA GMTs for each of the 13 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were logarithmically transformed for analysis. Confidence intervals (CIs) for GMT were back-transformed based on the Student t distribution for the mean logarithm of the titers. GMTs were calculated using all participants with available data for the specified blood draw. Here, "number of participants analyzed" signifies the participants who were evaluable at this timepoint and "n" signifies participants with a determinate OPA titer to the given serotype.
Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.
Posted
Geometric Mean
95% Confidence Interval
titer
1 month after Vaccination 1 for 13vPnC+QIV/Placebo, 1 Month After Vaccination 2 for Placebo+QIV/13vPnC
ID
Title
Description
OG000
13vPnC+QIV/Placebo
Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
OG001
Placebo+QIV/13vPnC
Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
Units
Counts
Participants
OG000427
OG001425
Title
Denominators
Categories
Serotype 1 (n= 419, 417)
Title
Measurements
OG00075(65.0 to 87.0)
OG00183(71.1 to 96.1)
Serotype 3 (n= 422, 418)
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Serotype 1: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).
GMT Ratio
0.9
2-Sided
95
0.74
1.12
Yes
Non-Inferiority or Equivalence
The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).
Primary
Hemagglutination Inhibition Assay (HAI) Geometric Mean Titers (GMTs) for Each Influenza Virus Strain in Quadrivalent Influenza Vaccine (QIV)
HAI GMTs were computed for assay titers collected 1 month after Vaccination 1 by vaccine sequence for each influenza virus strain (A/H1N1, A/H3N2, B/Brisbane and B/Massachusetts). CIs were back-transformations of a CI based on the Student t distribution for the mean logarithm of the titers. HAI GMTs were calculated using all participants with available data for the specified blood draw. Here, "number of participants analyzed" signifies participants with a determinate HAI titer to the given strain.
Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.
Posted
Geometric Mean
95% Confidence Interval
titer
1 month after Vaccination 1
ID
Title
Description
OG000
13vPnC+QIV/Placebo
Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
OG001
Placebo+QIV/13vPnC
Primary
Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 1
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).
Safety population included all participants who received at least 1 dose of vaccination.
Posted
Number
percentage of participants
Within 28 to 42 days after Vaccination 1
ID
Title
Description
OG000
13vPnC+QIV/Placebo
Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
OG001
Placebo+QIV/13vPnC
Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
Primary
Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 2
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).
Safety population included all participants who received at least 1 dose of vaccination. Here, "number of participants analyzed" signifies participants who were evaluable at this timepoint.
Posted
Number
percentage of participants
Within 28 to 42 days after Vaccination 2
ID
Title
Description
OG000
13vPnC+QIV/Placebo
Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
OG001
Placebo+QIV/13vPnC
Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
Primary
Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After 13vPnC Vaccination
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).
Safety population included all participants who received at least 1 dose of vaccination. Here, "number of participants analyzed" signifies participants who were evaluable at this timepoint.
Posted
Number
percentage of participants
Baseline (Vaccination 1) up to 28 to 42 Days after Vaccination 2
ID
Title
Description
OG000
13vPnC+QIV/Placebo
Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
OG001
Placebo+QIV/13vPnC
Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
Primary
Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) at the 6-Month Follow-up
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).
Safety population included all participants who received at least 1 dose of vaccination.
Posted
Number
percentage of participants
Within 168 to 196 days after Vaccination 2
ID
Title
Description
OG000
13vPnC+QIV/Placebo
Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
OG001
Placebo+QIV/13vPnC
Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
Secondary
Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)
Percentage of participants achieving predefined OPA antibody titer >= LLOQ for each of the 13 pneumococcal serotypes (LLOQs for each serotype OPA were set as- serotype 1: 18; serotype 3: 12; serotype 4: 21; serotype 5: 29; serotype 6A: 37; serotype 6B: 43; serotype 7F: 210; serotype 9V: 345; serotype 14: 35; serotype 18C: 31; serotype 19A: 18; serotype 19F: 48; and serotype 23F: 13) determined in blood samples of all participants were calculated. Exact, 2-sided 95% CIs based on the observed percentage of participants were determined by using Clopper and Pearson method. OPA titers were calculated using all participants with available data from 1 month after 13vPnC vaccination blood draw. Here, "number of participants analyzed" signifies the participants who were evaluable at this timepoint and "n" signifies participants with valid and determinate assay results to the specified serotype.
Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.
Posted
Number
95% Confidence Interval
percentage of participants
1 Month After Vaccination 1 for 13vPnC+QIV/Placebo, 1 month after Vaccination 2 for Placebo+QIV/13vPnC
ID
Title
Description
OG000
13vPnC+QIV/Placebo
Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
Secondary
Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 1 to Immediately Before 13vPnC Vaccination 1
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) 1 month after Vaccination 1 to before Vaccination 1 were computed using the logarithmically transformed assay results. CIs for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before Vaccination 1 and 1 month after Vaccination 1 blood draws. Here, "n" signifies participants with valid and determinate assay results for specified serotype at both the given visits. Number of participants who received at least 1 dose of 13vPnC during Vaccination 1 were analyzed.
Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.
Posted
Geometric Mean
95% Confidence Interval
fold rise
Immediately before Vaccination 1, 1 month after Vaccination 1
ID
Title
Description
OG000
13vPnC+QIV/Placebo
Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
Secondary
Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 2 to Immediately Before 13vPnC Vaccination 2
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) 1 month after Vaccination 2 to before Vaccination 2 (1 month after Vaccination 1) were computed using the logarithmically transformed assay results. CIs for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before Vaccination 2 and 1 month after Vaccination 2 blood draws. Here, "number of participants analyzed" signifies total participants who were evaluable at this timepoint and "n" signifies participants with valid and determinate assay results for specified serotype at both the given visits. Number of participants who received at least 1 dose of 13vPnC during Vaccination 2 were analyzed.
Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.
Posted
Geometric Mean
95% Confidence Interval
fold rise
Immediately before Vaccination 2, 1 month after Vaccination 2
ID
Title
Description
OG000
Placebo+QIV/13vPnC
Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
Secondary
Percentage of Participants Achieving Seroconversion in Hemagglutination Inhibition Assay (HAI) Titers
Percentage of participants achieving seroconversion in HAI titers was defined as the percentage of participants with either before Vaccination 1 (pre-vaccination 1) HAI titer less than <1:10 and after Vaccination 1 (post-vaccination 1) HAI titer >=1:40 or before Vaccination 1 (pre-vaccination 1) HAI titer >=1:10 and a minimum 4-fold rise in after Vaccination 1 (post-vaccination 1) HAI antibody titer with respect to before Vaccination 1 (pre-vaccination) titer for influenza virus strains. Here, "number of participants analyzed" signifies the participants who were evaluable at this timepoint.
Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.
Posted
Number
95% Confidence Interval
percentage of participants
Immediately before Vaccination 1, 1 month after Vaccination 1
ID
Title
Description
OG000
13vPnC+QIV/Placebo
Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
OG001
Secondary
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition Assay (HAI) 1 Month After Vaccination 1 to Immediately Before Vaccination 1
Fold rise 1 month after Vaccination 1 to before Vaccination 1 was calculated for each influenza virus strain (A/H1N1, A/H3N2, B/Brisbane and B/Massachusetts). GMFRs were calculated using all participants with available data from both the specified blood draws. CI for the GMFRs were back transformations of a CI based on the Student t distribution for mean fold rise. Here, "number of participants analyzed" signifies participants with valid and determinate assay results for specified strain at both the specified blood draws.
Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.
Posted
Geometric Mean
95% Confidence Interval
fold rise
Immediately before Vaccination 1, 1 month after Vaccination 1
ID
Title
Description
OG000
13vPnC+QIV/Placebo
Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
OG001
Placebo+QIV/13vPnC
Time Frame
Not provided
Description
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
13vPnC+QIV/Placebo: After Vaccination 1
All participants received 0.5 mL single dose of 13vPnC vaccine intramuscularly along with a dose of QIV (as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed from Vaccination 1 up to before Vaccination 2.
6
439
62
439
EG001
Placebo+QIV/13vPnC: After Vaccination 1
All participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection (as per official recommendations) at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were accessed from Vaccination 1 up to before Vaccination 2.
0
437
52
437
EG002
13vPnC+QIV/Placebo: After Vaccination 2
All participants received 0.5 mL single dose of 13vPnC vaccine intramuscularly along with a dose of QIV (as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed from after Vaccination 2 up to before 1 month blood draw after Vaccination 2.
7
431
42
431
EG003
Placebo+QIV/13vPnC: After Vaccination 2
All participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection (as per official recommendations) at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed from after Vaccination 2 up to before 1 month blood draw after Vaccination 2.
6
432
51
432
EG004
13vPnC+QIV/Placebo: After 13vPnC Vaccination
All participants received 0.5 mL single dose of 13vPnC vaccine intramuscularly along with a dose of QIV (as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed after 13vPnC Vaccination.
6
439
62
439
EG005
Placebo+QIV/13vPnC: After 13vPnC Vaccination
All participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection (as per official recommendations) at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed after 13vPnC Vaccination.
6
432
51
432
EG006
13vPnC+QIV/Placebo: at 6-Month Follow-up
All participants received 0.5 mL single dose of 13vPnC vaccine intramuscularly along with a dose of QIV (as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed from blood draw 1 month blood after Vaccination 2 to 6-month follow-up.
5
439
6
439
EG007
Placebo+QIV/13vPnC: at 6-Month Follow-up
All participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection (as per official recommendations) at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed from blood draw 1 month blood after Vaccination 2 to 6-month follow-up.
6
437
6
437
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Colitis
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG0030 affected432 at risk
EG0041 affected439 at risk
EG0050 affected432 at risk
EG0060 affected439 at risk
EG0070 affected437 at risk
Chest pain
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0010 affected437 at risk
EG0021 affected431 at risk
EG003
Gangrene
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Localised infection
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0022 affected431 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Cardiogenic shock
Cardiac disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0021 affected431 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Diverticulum intestinal haemorrhagic
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0021 affected431 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0021 affected431 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0021 affected431 at risk
EG003
Incisional hernia
Injury, poisoning and procedural complications
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0021 affected431 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Surgical failure
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Influenza
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Bone loss
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Bronchitis chronic
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Syncope
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Ovarian cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Angina pectoris
Cardiac disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0012 affected437 at risk
EG0020 affected431 at risk
EG0031 affected432 at risk
EG0040 affected439 at risk
EG0051 affected432 at risk
EG0060 affected439 at risk
EG0070 affected437 at risk
Cardiac failure congestive
Cardiac disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0002 affected439 at risk
EG0012 affected437 at risk
EG0021 affected431 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0011 affected437 at risk
EG0020 affected431 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0011 affected437 at risk
EG0020 affected431 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0011 affected437 at risk
EG0023 affected431 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0011 affected437 at risk
EG0020 affected431 at risk
EG003
Rectal prolapse
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0011 affected437 at risk
EG0020 affected431 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0011 affected437 at risk
EG0020 affected431 at risk
EG003
Injection site pain
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0008 affected439 at risk
EG0012 affected437 at risk
EG0020 affected431 at risk
EG003
Pyrexia
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0014 affected437 at risk
EG0020 affected431 at risk
EG003
Injection site erythema
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0002 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Injection site induration
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0002 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Injection site swelling
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0002 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Vaccination site pain
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0012 affected437 at risk
EG0021 affected431 at risk
EG003
Asthenia
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0011 affected437 at risk
EG0021 affected431 at risk
EG003
Peripheral swelling
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0011 affected437 at risk
EG0020 affected431 at risk
EG003
Vaccination site reaction
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Vaccination site induration
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0011 affected437 at risk
EG0020 affected431 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0011 affected437 at risk
EG0020 affected431 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0008 affected439 at risk
EG0014 affected437 at risk
EG0023 affected431 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0003 affected439 at risk
EG0014 affected437 at risk
EG0024 affected431 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0003 affected439 at risk
EG0013 affected437 at risk
EG0024 affected431 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0005 affected439 at risk
EG0011 affected437 at risk
EG0022 affected431 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0002 affected439 at risk
EG0012 affected437 at risk
EG0021 affected431 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0002 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0011 affected437 at risk
EG0020 affected431 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0002 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0011 affected437 at risk
EG0020 affected431 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0022 affected431 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Gastrointestinal viral infection
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0011 affected437 at risk
EG0021 affected431 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Groin infection
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0011 affected437 at risk
EG0021 affected431 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0011 affected437 at risk
EG0021 affected431 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0011 affected437 at risk
EG0020 affected431 at risk
EG003
Chemical burn of skin
Injury, poisoning and procedural complications
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Chemical burns of eye
Injury, poisoning and procedural complications
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0011 affected437 at risk
EG0024 affected431 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0011 affected437 at risk
EG0020 affected431 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Skeletal injury
Injury, poisoning and procedural complications
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Splinter
Injury, poisoning and procedural complications
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0011 affected437 at risk
EG0020 affected431 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Blood pressure increased
Investigations
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0011 affected437 at risk
EG0020 affected431 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0011 affected437 at risk
EG0020 affected431 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0002 affected439 at risk
EG0011 affected437 at risk
EG0020 affected431 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0003 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0011 affected437 at risk
EG0020 affected431 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0011 affected437 at risk
EG0020 affected431 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0011 affected437 at risk
EG0020 affected431 at risk
EG003
Synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0011 affected437 at risk
EG0020 affected431 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0011 affected437 at risk
EG0020 affected431 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0011 affected437 at risk
EG0020 affected431 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Headache
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0013 affected437 at risk
EG0024 affected431 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0010 affected437 at risk
EG0022 affected431 at risk
EG003
Nerve compression
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0011 affected437 at risk
EG0020 affected431 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Depression
Psychiatric disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0011 affected437 at risk
EG0020 affected431 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0011 affected437 at risk
EG0020 affected431 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0011 affected437 at risk
EG0020 affected431 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0011 affected437 at risk
EG0020 affected431 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0011 affected437 at risk
EG0021 affected431 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0002 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0011 affected437 at risk
EG0021 affected431 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0011 affected437 at risk
EG0020 affected431 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0011 affected437 at risk
EG0020 affected431 at risk
EG003
Pulmonary pain
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0010 affected437 at risk
EG0021 affected431 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0012 affected437 at risk
EG0020 affected431 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0011 affected437 at risk
EG0020 affected431 at risk
EG003
Haematoma
Vascular disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Atrioventricular block first degree
Cardiac disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0021 affected431 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0021 affected431 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0021 affected431 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0021 affected431 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0021 affected431 at risk
EG003
Loose tooth
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0021 affected431 at risk
EG003
Chills
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0021 affected431 at risk
EG003
Injection site haematoma
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Oedema peripheral
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Sepsis
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0021 affected431 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0021 affected431 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0021 affected431 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0021 affected431 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0021 affected431 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0021 affected431 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Electrocardiogram T wave abnormal
Investigations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Lactic acidosis
Metabolism and nutrition disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0021 affected431 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0021 affected431 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0021 affected431 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Urine odour abnormal
Renal and urinary disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0021 affected431 at risk
EG003
Testicular pain
Reproductive system and breast disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0021 affected431 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0021 affected431 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0021 affected431 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0021 affected431 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Hypertension
Vascular disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0021 affected431 at risk
EG003
Hypotension
Vascular disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0021 affected431 at risk
EG003
Cardiomyopathy
Cardiac disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Food allergy
Immune system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Osteopenia
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Pelvic haematoma
Reproductive system and breast disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Aortic arteriosclerosis
Vascular disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected439 at risk
EG0010 affected437 at risk
EG0020 affected431 at risk
EG003
Fatigue
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected439 at risk
EG0011 affected437 at risk
EG0020 affected431 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1--800--718--1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
D007251
Influenza, Human
Ancestor Terms
ID
Term
D012141
Respiratory Tract Infections
D007239
Infections
D009976
Orthomyxoviridae Infections
D012327
RNA Virus Infections
D014777
Virus Diseases
D012140
Respiratory Tract Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
483
Male
BG000205
BG001188
BG002393
41
(36.2 to 46)
OG00149(43.6 to 55.3)
Serotype 4 (n= 412, 417)
Title
Measurements
OG000587(489.9 to 702.5)
OG001824(692.2 to 980)
Serotype 5 (n= 423, 414)
Title
Measurements
OG00097(83.8 to 111.7)
OG001101(86.6 to 117.2)
Serotype 6A (n= 420, 415)
Title
Measurements
OG000953(805.7 to 1126.3)
OG0011413(1203.3 to 1659.4)
Serotype 6B (n= 414, 405)
Title
Measurements
OG000867(722.3 to 1039.6)
OG0011041(860.5 to 1260)
Serotype 7F (n= 424, 419)
Title
Measurements
OG000651(582.4 to 728)
OG001670(599.7 to 748.5)
Serotype 9V (n= 419, 415)
Title
Measurements
OG000699(613.7 to 797.2)
OG001838(734.2 to 957.5)
Serotype 14 (n= 421, 416)
Title
Measurements
OG000574(496.8 to 663)
OG001760(665.6 to 868)
Serotype 18C (n= 420, 414)
Title
Measurements
OG000713(598.9 to 849.9)
OG001865(726.4 to 1030.5)
Serotype 19A (n= 425, 419)
Title
Measurements
OG000337(294.9 to 384.6)
OG001390(344.4 to 441.1)
Serotype 19F (n= 423, 416)
Title
Measurements
OG000324(274.8 to 382.5)
OG001360(302.7 to 427.9)
Serotype 23F (n= 421, 417)
Title
Measurements
OG000278(223.9 to 344.7)
OG001364(294.3 to 451.3)
OG000
OG001
Serotype 3: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).
GMT Ratio
0.8
2-Sided
95
0.70
0.98
Yes
Non-Inferiority or Equivalence
The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 4: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).
GMT Ratio
0.7
2-Sided
95
0.55
0.91
Yes
Non-Inferiority or Equivalence
The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 5: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).
GMT Ratio
1.0
2-Sided
95
0.78
1.18
Yes
Non-Inferiority or Equivalence
The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 6A: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).
GMT Ratio
0.7
2-Sided
95
0.53
0.85
Yes
Non-Inferiority or Equivalence
The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 6B: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).
GMT Ratio
0.8
2-Sided
95
0.64
1.08
Yes
Non-Inferiority or Equivalence
The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 7F: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).
GMT Ratio
1.0
2-Sided
95
0.83
1.14
Yes
Non-Inferiority or Equivalence
The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 9V: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).
GMT Ratio
0.8
2-Sided
95
0.69
1.0
Yes
Non-Inferiority or Equivalence
The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 14: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).
GMT Ratio
0.8
2-Sided
95
0.62
0.92
Yes
Non-Inferiority or Equivalence
The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 18C: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).
GMT Ratio
0.8
2-Sided
95
0.64
1.06
Yes
Non-Inferiority or Equivalence
The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 19A: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).
GMT Ratio
0.9
2-Sided
95
0.72
1.04
Yes
Non-Inferiority or Equivalence
The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 19F: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).
GMT Ratio
0.9
2-Sided
95
0.71
1.14
Yes
Non-Inferiority or Equivalence
The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 23F: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).
GMT Ratio
0.8
2-Sided
95
0.56
1.03
Yes
Non-Inferiority or Equivalence
The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).
Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
Units
Counts
Participants
OG000427
OG001430
Title
Denominators
Categories
Strain: A/H1N1
Title
Measurements
OG000115(104.0 to 126.8)
OG001113(101.6 to 124.7)
Strain: A/H3N2
Title
Measurements
OG000226(206.1 to 248.5)
OG001196(178.0 to 216.1)
Strain: B/Brisbane
Title
Measurements
OG00028(25.7 to 31.0)
OG00126(23.7 to 28.7)
Strain: B/Massachusetts
Title
Measurements
OG00045(41.0 to 50.3)
OG00143(39.1 to 48.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Strain A/H1N1: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).
GMT Ratio
1.0
2-Sided
95
0.88
1.18
Yes
Non-Inferiority or Equivalence
The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).
OG000
OG001
Strain A/H3N2: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).
GMT Ratio
1.2
2-Sided
95
1.01
1.32
Yes
Non-Inferiority or Equivalence
The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).
OG000
OG001
Strain B/Brisbane: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).
GMT Ratio
1.1
2-Sided
95
0.95
1.24
Yes
Non-Inferiority or Equivalence
The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).
OG000
OG001
Strain B/Massachusetts: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).
GMT Ratio
1.0
2-Sided
95
0.90
1.21
Yes
Non-Inferiority or Equivalence
The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).
Units
Counts
Participants
OG000439
OG001437
Title
Denominators
Categories
AE
Title
Measurements
OG00015.3
OG00111.9
SAE
Title
Measurements
OG0001.4
OG0010
Units
Counts
Participants
OG000431
OG001432
Title
Denominators
Categories
AE
Title
Measurements
OG00010.4
OG00112.5
SAE
Title
Measurements
OG0001.6
OG0011.4
Units
Counts
Participants
OG000439
OG001432
Title
Denominators
Categories
AE
Title
Measurements
OG00015.3
OG00112.5
SAE
Title
Measurements
OG0001.4
OG0011.4
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
AE: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC+QIV /placebo - placebo+QIV/13vPnC, expressed as a percentage.
Percentage Difference
2.8
2-Sided
95
-1.9
7.4
No
Superiority or Other
OG000
OG001
SAE: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC+QIV /placebo - placebo+QIV/13vPnC, expressed as a percentage.
Percentage Difference
-0.0
2-Sided
95
-1.8
1.7
No
Superiority or Other
Units
Counts
Participants
OG000439
OG001437
Title
Denominators
Categories
AE
Title
Measurements
OG0002.5
OG0012.7
SAE
Title
Measurements
OG0001.1
OG0011.4
OG001
Placebo+QIV/13vPnC
Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
Units
Counts
Participants
OG000427
OG001425
Title
Denominators
Categories
Serotype 1 (n= 419, 417)
Title
Measurements
OG00077.3(73.0 to 81.3)
OG00180.1(75.9 to 83.8)
Serotype 3 (n= 422, 418)
Title
Measurements
OG00079.4(75.2 to 83.1)
OG00183.7(79.8 to 87.1)
Serotype 4 (n= 412, 417)
Title
Measurements
OG00088.6(85.1 to 91.5)
OG00192.1(89.1 to 94.5)
Serotype 5 (n= 423, 414)
Title
Measurements
OG00074.5(70.0 to 78.6)
OG00172.7(68.1 to 76.9)
Serotype 6A (n= 420, 415)
Title
Measurements
OG00090.5(87.3 to 93.1)
OG00194.2(91.5 to 96.3)
Serotype 6B (n= 414, 405)
Title
Measurements
OG00085.0(81.2 to 88.3)
OG00186.4(82.7 to 89.6)
Serotype 7F (n= 424, 419)
Title
Measurements
OG00082.3(78.3 to 85.8)
OG00183.5(79.6 to 87.0)
Serotype 9V (n= 419, 415)
Title
Measurements
OG00065.2(60.4 to 69.7)
OG00171.3(66.7 to 75.6)
Serotype 14 (n= 421, 416)
Title
Measurements
OG00091.4(88.4 to 93.9)
OG00195.2(92.7 to 97.0)
Serotype 18C (n= 420, 414)
Title
Measurements
OG00088.8(85.4 to 91.7)
OG00191.3(88.2 to 93.8)
Serotype 19A (n= 425, 419)
Title
Measurements
OG00095.5(93.1 to 97.3)
OG00197.4(95.4 to 98.7)
Serotype 19F (n= 423, 416)
Title
Measurements
OG00079.9(75.8 to 83.6)
OG00179.6(75.4 to 83.3)
Serotype 23F (n= 421, 417)
Title
Measurements
OG00080.3(76.2 to 84.0)
OG00184.2(80.3 to 87.5)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Serotype 1: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.
Chan and Zhang method
0.333
Percentage Difference
-2.8
2-Sided
95
-8.3
2.8
No
Superiority or Other
OG000
OG001
Serotype 3: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.
Chan and Zhang method
0.105
Percentage Difference
-4.3
2-Sided
95
-9.6
0.9
No
Superiority or Other
OG000
OG001
Serotype 4: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.
Chan and Zhang method
0.090
Percentage Difference
-3.5
2-Sided
95
-7.6
0.6
No
Superiority or Other
OG000
OG001
Serotype 5: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.
Chan and Zhang method
0.590
Percentage Difference
1.8
2-Sided
95
-4.2
7.8
No
Superiority or Other
OG000
OG001
Serotype 6A: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.
Chan and Zhang method
0.044
Percentage Difference
-3.7
2-Sided
95
-7.5
-0.1
No
Superiority or Other
OG000
OG001
Serotype 6B: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.
Chan and Zhang method
0.574
Percentage Difference
-1.4
2-Sided
95
-6.2
3.4
No
Superiority or Other
OG000
OG001
Serotype 7F: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.
Chan and Zhang method
0.648
Percentage Difference
-1.2
2-Sided
95
-6.3
3.9
No
Superiority or Other
OG000
OG001
Serotype 9V: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.
Chan and Zhang method
0.057
Percentage Difference
-6.2
2-Sided
95
-12.5
0.2
No
Superiority or Other
OG000
OG001
Serotype 14: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.
Chan and Zhang method
0.030
Percentage Difference
-3.7
2-Sided
95
-7.3
-0.3
No
Superiority or Other
OG000
OG001
Serotype 18C: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.
Chan and Zhang method
0.233
Percentage Difference
-2.5
2-Sided
95
-6.6
1.6
No
Superiority or Other
OG000
OG001
Serotype 19A: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.
Chan and Zhang method
0.152
Percentage Difference
-1.8
2-Sided
95
-4.5
0.7
No
Superiority or Other
OG000
OG001
Serotype 19F: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.
Chan and Zhang method
0.926
Percentage Difference
0.3
2-Sided
95
-5.1
5.8
No
Superiority or Other
OG000
OG001
Serotype 23F: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.
Chan and Zhang method
0.143
Percentage Difference
-3.9
2-Sided
95
-9.1
1.3
No
Superiority or Other
Units
Counts
Participants
OG000427
Title
Denominators
Categories
Serotype 1 (n= 417)
Title
Measurements
OG0003.6(3.20 to 4.14)
Serotype 3 (n= 419)
Title
Measurements
OG0003.4(3.05 to 3.85)
Serotype 4 (n= 399)
Title
Measurements
OG0009.1(7.33 to 11.18)
Serotype 5 (n= 422)
Title
Measurements
OG0003.0(2.70 to 3.43)
Serotype 6A (n= 408)
Title
Measurements
OG00013.7(11.30 to 16.62)
Serotype 6B (n= 391)
Title
Measurements
OG0008.9(7.29 to 10.87)
Serotype 7F (n= 417)
Title
Measurements
OG0002.7(2.40 to 2.98)
Serotype 9V (n= 405)
Title
Measurements
OG0002.1(1.92 to 2.38)
Serotype 14 (n= 411)
Title
Measurements
OG0002.0(1.78 to 2.30)
Serotype 18C (n= 417)
Title
Measurements
OG0004.0(3.38 to 4.74)
Serotype 19A (n= 424)
Title
Measurements
OG0003.7(3.20 to 4.28)
Serotype 19F (n= 419)
Title
Measurements
OG0004.2(3.60 to 4.87)
Serotype 23F (n= 418)
Title
Measurements
OG0008.7(7.07 to 10.61)
Units
Counts
Participants
OG000425
Title
Denominators
Categories
Serotype 1 (n =413)
Title
Measurements
OG0003.6(3.19 to 4.16)
Serotype 3 (n= 414)
Title
Measurements
OG0003.9(3.47 to 4.42)
Serotype 4 (n= 391)
Title
Measurements
OG00010.4(8.28 to 12.94)
Serotype 5 (n= 411)
Title
Measurements
OG0003.3(2.87 to 3.72)
Serotype 6A (n= 399)
Title
Measurements
OG00017.9(14.73 to 21.86)
Serotype 6B (n= 382)
Title
Measurements
OG0009.5(7.69 to 11.67)
Serotype 7F (n= 407)
Title
Measurements
OG0002.7(2.41 to 3.03)
Serotype 9V (n= 399)
Title
Measurements
OG0002.4(2.12 to 2.71)
Serotype 14 (n= 406)
Title
Measurements
OG0002.3(1.98 to 2.60)
Serotype 18C (n= 408)
Title
Measurements
OG0006.3(5.21 to 7.51)
Serotype 19A (n= 416)
Title
Measurements
OG0004.6(4.02 to 5.35)
Serotype 19F (n= 410)
Title
Measurements
OG0004.8(4.12 to 5.69)
Serotype 23F (n= 412)
Title
Measurements
OG00012.9(10.42 to 15.88)
Placebo+QIV/13vPnC
Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
Units
Counts
Participants
OG000427
OG001430
Title
Denominators
Categories
Strain: A/H1N1
Title
Measurements
OG00029.3(25.0 to 33.8)
OG00124.2(20.2 to 28.5)
Strain: A/H3N2
Title
Measurements
OG00027.9(23.7 to 32.4)
OG00131.6(27.3 to 36.3)
Strain: B/Brisbane
Title
Measurements
OG00021.3(17.5 to 25.5)
OG00122.3(18.5 to 26.6)
Strain: B/Massachusetts
Title
Measurements
OG00023.2(19.3 to 27.5)
OG00124.7(20.6 to 29.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Strain A/H1N1: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.
Chan and Zhang method
0.094
Percentage Difference
5.1
2-Sided
95
-0.9
11.0
Yes
Non-Inferiority or Equivalence
The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).
OG000
OG001
Strain A/H3N2: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.
Chan and Zhang method
0.232
Percentage Difference
-3.8
2-Sided
95
-9.9
2.4
Yes
Non-Inferiority or Equivalence
The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).
OG000
OG001
Strain B/Brisbane: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.
Chan and Zhang method
0.734
Percentage Difference
-1.0
2-Sided
95
-6.6
4.5
Yes
Non-Inferiority or Equivalence
The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).
OG000
OG001
Strain B/Massachusetts: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.
Chan and Zhang method
0.627
Percentage Difference
-1.5
2-Sided
95
-7.2
4.3
Yes
Non-Inferiority or Equivalence
The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).
Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.